Medical device for providing port-like access to a mammalian urinary bladder and methods of inserting and utilizing the same

ABSTRACT

A medical device for providing direct port-like endoscopic access to the urinary bladder of a patient and a method of utilizing and inserting the medical device. The medical device can include a hollow tube with a main channel and a separate channel, a cap with an inflation port and a hollow flexible stem fluidly connecting the inflation port and the separate channel. A method can include inserting a needle above the pubic symphysis of a mammal, threading a guide wire through the needle, removing the needle and inserting the medical device. The method can optionally include determining measuring the depth between the skin surface of the patient&#39;s suprapubic region and urinary bladder.

TECHNICAL FIELD

The present disclosure relates generally to a medical device forproviding direct port-like endoscopic access to the urinary bladder of apatient. More particularly, the medical device is low profile, designedfor long term use and allows an operator to drain the urinary bladder oraccess the urinary bladder with minimal effort and without using thepatient's urethra.

BACKGROUND

Access to the urinary bladder of a patient is sometimes necessary totreat a patient or to drain urine from the bladder of a patient. Forexample, in some instances the normal urinary flow of a patient may beblocked for one or more reasons. Some of these reasons include theswelling of the prostate (benign prostatic hypertrophy), congenitaldefects of the urinary tract, traumatic disruption of the urethra,obstructions such as kidney stones passed into the urethra, and cancer.When the normal urinary flow of the patient is obstructed asurgically-created connection between the urinary bladder and the skin,sometimes referred to as suprapubic cystostomy, is used to drain urinefrom the bladder. In a suprapubic cystostomy, medical personnel insert acatheter into the patient to allow urine to drain from the bladder. Thecatheters used in these procedures have several disadvantages, includingtheir bulky size which leaves the patient with a large catheterprotruding from the placement site. In some circumstances, medicalpersonnel may place a Foley catheter into the patient's bladder via theurethra. This is uncomfortable for the patient and can easily becomeinfected unless necessary precautions are taken, for example, drinkingsufficient amounts of water, infrequently disconnecting the drainage bagand limiting sexual activity. As sexual activity of the elderlypopulation increases the need to decrease or limit sexual activity inelderly patients has become an increasing concern.

Another instance where access to the urinary bladder of a patient issometimes necessary is when medical personnel need to performintra-bladder or intra-urethral procedures, for example, removingbladder stones, performing bladder biopsies, performing retrogradepyelograms, performing cystograms, and ureteral stent placement andremoval. In these instances medical personnel often use a cystoscope oralternative devices to provide both visual and mechanical access to theimmediate and surrounding procedure area via a patient's urethra. Eachtime access is necessary, a narrow tube is passed through the urethrainto the bladder which allows medical personnel to use a light, camera,and tools to diagnose and treat bladder problems.

Like the use of a Foley catheter, this procedure is uncomfortable forthe patient and requires repeating the entire process every time accessis necessary.

SUMMARY

A device for providing direct port-like endoscopic access to the bladderof a patient to assist the operator in performing intra-bladder orintra-urethral procedures, e.g., removing bladder stones, performingbladder biopsies, performing retrograde pyelograms, performingcystograms, ureteral stent placement and removal, flexible ureteroscopy,performing bladder instillations, bladder cycling and bladder training,mucous removal, and matrix stone removal.

In some embodiments, the device improves a patient's ability to draintheir bladder. The device is easier to place and may be placed in anexisting suprapubic tract by stage and/or primary placement. The deviceallows for easier exchange in the office rather than operating roomafter initial placement and may allow for patients to change at home, orbe changed by nursing home staff or visiting nurses, thereby increasingphysician availability for new patient visits and decreasing patient andinsurance costs for repeat physician office procedural visits.

In some embodiments, a medical device comprises a continuous hollow tubefor spanning the distance between an exterior surface of a patient'ssuprapubic region and the patients urinary bladder having a diameterbetween 10 french and 40 french and a length between 0.8 cm and 15 cm.The hollow tube has an open proximal end and an open distal end, theproximal end of the hollow tube being longitudinally more rigid than thedistal end.

The medical device may also comprise a first cap having a top surfaceand bottom surface that is operatively configured for securely attachingto the proximal end of the tube. The cap covers the open proximal end ofthe tube when securely attached to the proximal end of the tube and thebottom surface of the cap is recessed within the proximal end of thetube when securely attached.

The medical device may further comprise a hollow flexible stem fluidlyconnecting the cap and the proximal end of the hollow tube so thatliquid may pass into the bottom surface of the cap, through the hollowflexible stem and into a separate channel within the hollow tube. Thefluidly separate channel runs from the proximal end of the hollow tubetoward the distal end of the hollow tube and the hollow flexible stem ispermanently attached to the hollow tube below the open proximal end ofthe hollow tube.

The medical device may also comprise an inflation port on the bottomsurface of the cap, the inflation port is operatively configured toreceive liquid via a syringe so when the cap is not securely attached tothe proximal end of the tube, liquid may be injected via the inflationport and travel from the cap, through the hollow flexible stem and downthe separate channel within the hollow tube.

In some embodiments a medical device may comprise a second cap having atop surface and a bottom surface that is operatively configured tosecurely attach to the proximal end of the tube. The second cap may haveat least one port from the top surface through to the bottom surface. Inaddition a medical device may comprise a one way valve located withinthe tube of the medical device to prevent liquid from traveling from thepatient's urinary bladder to the proximal surface of the patient'ssuprapubic region when the first cap is not securely attached to theproximal end of the tube.

A variation of a medical device may comprise an inflatable balloon alongthe exterior surface (or partially interior surface) of the hollow tubeand in fluid communication with the inflation port via the separatechannel within the hollow tube.

In certain embodiments, a medical device of the present disclosure willsit substantially flush with the skin of the suprapubic region of thepatient after insertion of the device into the patient. And in someembodiments the inflation port of the device sits at least partiallybeneath the skin of the suprapubic region of the patient after insertionof the device and when the cap is securely attached to the proximal endof the tube.

A medical device of the present disclosure, in some instances, will havea medial region located between the proximal end and the distal end ofthe hollow tube where the rigidity of the medial region is less than theproximal end and greater than the distal end.

In an embodiment of the present disclosure a method for inserting amedical device is disclosed, comprising the following steps: Inserting aneedle from a patient's exterior surface of a suprapubic skin through tothe patient's abdominal region and into the patient's urinary bladder tocreate a tract; threading a guide wire through the needle so the guidewire travels from the suprapubic skin of the patient into the urinarybladder of the patient; removing the needle while leaving the guide wirein the tract; dilating the tract to a desired width; measuring adistance between the patient's suprapubic skin and the patient's urinarybladder via the tract; and inserting a medical device suitable for usebased on the previously measure distance.

A method for replacing a medical device is disclosed in the presentdisclosure, one embodiment comprising: Placing a guide wire from apatient's suprapubic skin through the patient's abdominal region andinto the patient's urinary bladder, the guide wire traveling from thesuprapubic skin into the urinary bladder within a previously placedmedical device; removing the previously placed medical device by slidingthe device along the guide wire and away from the patient; filling thebladder of the patient; measuring a distance between the patient'ssuprapubic skin and the patient's urinary bladder; selecting a secondmedical device suitable for use based on the previously measuredistance; inserting the selected medical device; and draining theurinary bladder of the patient.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 illustrates a side profile of an embodiment of the medical deviceimplanted in a patient with the first cap unsecured to the hollow tube.

FIG. 2 illustrates a side profile of an embodiment of the medical deviceimplanted in a patient with the first cap secured to the hollow tube.

FIG. 3 illustrates a side profile of an embodiment of the medical deviceimplanted in a patient with the first cap unsecured to the hollow tubeand a syringe.

FIG. 4 illustrates an alternative side profile, rotated 90 degrees fromFIG. 1-3, of an embodiment of the medical device with an emphasis on theproximal end of the medical device.

FIG. 5 illustrates a top view of an embodiment of the medical device.

FIG. 6 illustrates a top view of an embodiment of the medical devicewith an emphasis on one embodiment of the valve located at the proximalend of the medical device.

FIG. 7 illustrates a top view of an embodiment of the medical devicewith an emphasis on an alternative embodiment of the valve located atthe proximal end of the medical device.

FIG. 8 illustrates a side profile, 90 degrees from FIG. 1-3, of anembodiment of the medical device with an emphasis on the flexibility ofthe wings at the proximal end of the medical device.

FIG. 9 a illustrates a side profile, 90 degrees from FIG. 1-3, of anembodiment of the medical device with an emphasis on the configurationfor receiving a second cap.

FIG. 9 b illustrates a side profile, 90 degrees from FIG. 1-3, of anembodiment of the medical device with an emphasis on the configurationfor receiving a second cap.

FIG. 10 illustrates six different embodiments of a second cap of thepresent disclosure having various numbers and configurations of portswithin each cap.

FIG. 11 illustrates steps medical personnel may take for replacing anold medical device with a new medical device of the present disclosure.

FIG. 12 illustrates steps medical personnel may take for replacing anold medical device with a new medical device of the present disclosure.

FIG. 13 illustrates steps medical personnel may take for replacing anold medical device with a new medical device of the present disclosure.

FIG. 14 illustrates steps medical personnel may take for inserting a newmedical device of the present disclosure where a tract did notpreviously exist.

FIG. 15 illustrates steps medical personnel may take for inserting a newmedical device of the present disclosure where a tract did notpreviously exist.

FIG. 16 illustrates an embodiment where the hollow tube of the medicaldevice has three different regions of longitudinal rigidity.

DETAILED DESCRIPTION

There is a need in the art for low-profile long-term device that allowsport-like access to the urinary bladder of a patient without utilizing apatient's urethra. The device should allow a patient's bladder to drainas well as permit medical personnel access to the urinary bladder todiagnose and treat bladder problems. In addition, the low profile of thedevice should limit or decrease inadvertent removal of the device byconfused patients, i.e., patients suffering from dementia, neuralinjury, trauma, medication or in the internal care unit. The presentdisclosure overcomes the shortcomings of the prior art and addressesthese needs in the art.

Referring now to the drawings wherein like reference numerals designateidentical or corresponding parts throughout the several views, anembodiment of medical device implanted in a patient with the first capunsecured to the hollow tube is shown in FIG. 1. An embodiment ofmedical device a continuous hollow tube 16 for spanning the distancebetween an exterior surface of a patient's suprapubic region 8 and thepatient's urinary bladder 10 having a diameter between 10 french and 40french and a length between 0.8 cm and 15 cm, the hollow tube having anopen proximal end 3 and an open distal end 14, the proximal end 3 of thehollow tube 16 being longitudinally more rigid than the distal end 14.The first cap 2 having a top surface and bottom surface that isoperatively configured for securely attaching to the proximal end 3 ofthe tube 16, the cap covering the open proximal end 3 of the tube 16when securely attached to the proximal end 3 of the tube 16, the bottomsurface of the cap 1 being recessed within the proximal end 3 of thetube 16 upon secure attachment.

A hollow flexible stem 26 fluidly connects the cap 2 and the proximalend 3 of the hollow tube 16 so that liquid may pass into the bottomsurface of the cap 1, through the hollow flexible stem 26 and into aseparate channel 25 within the hollow tube 16. The fluidly separatechannel 25 runs from the proximal end 3 of the hollow tube 16 toward thedistal end 14 of the hollow tube 16, and the hollow flexible stem 26 ispermanently attached to the hollow tube 16 below the open proximal end 3of the hollow tube 16.

The medical device may further comprise an inflation port 6 on thebottom surface of the cap 2. The inflation port 6 is operativelyconfigured to receive liquid via a syringe 29 so when the cap 2 is notsecurely attached to the proximal end 3 of the tube 16 liquid may beinjected via the inflation port 6 and travel from the cap 2, through thehollow flexible stem 26 and down the separate channel 25 within thehollow tube 16.

In some embodiments, the diameter of the hollow tube 16 is between 10french and 50 french (6 Fr-50 Fr). However, in additional embodimentsthe diameter of the hollow tube may change depending on the patient'sneeds and the medical personnel's preferences. For example, the medicalpersonnel may require a larger diameter to permit the use of multiple ordifferent instruments depending on the anticipated medical procedure. Inanother example the size of the patient may dictate the diameter of thehollow tube, i.e., a patient with a larger suprapubic region 8 mass ordistance between the suprapubic region 8 and bladder 10 may require alarger diameter tube 16.

In certain embodiments the diameter of the tube 16 will be between 15french and 35 french, between 20 french and 30 french, between 10 frenchand 30 french, between 10 french and 20 french, between 20 french and 40french or between 30 french and 40 french.

In some embodiments the diameter of the tube will be greater than 10french, greater than 20 french, greater than 30 french or greater than40 french. In other embodiments the diameter of the tube will be lessthan 50 french, less than 40 french, less than 30 french or less than 20french.

It will be appreciated that in some embodiments the tube 16 has asubstantially continuous diameter from the proximal end 3 to the distalend 14. However, in some embodiments the diameter of the tube 16 maychange. For example, the proximal region 22 of the tube may be onediameter, while the distal region 18 of the tube 16 is a similar ordifferent diameter and the medial region 20 of the tube is a similar ordifferent diameter. The difference in diameters may be important tohelping control how rigid the tube 16 is or helping to prevent themedical device from accidently coming out. In some embodiments thediameter of the tube 16 will gradually increase or decrease from theproximal end 3 to the distal end 14.

In some embodiments, the length of the hollow tube 16 is between 0.8 cmand 40 cm. However, in additional embodiments the length of the hollowtube may change depending on the patient's needs and the medicalpersonnel's preferences. For example the size of the patient may thelength of the hollow tube, i.e., a patient with a larger suprapubicregion 8 mass or distance between the suprapubic region 8 and bladder 10may require a longer tube 16.

In certain embodiments the length of the tube 16 will be between 5 cmand 25 cm, between 10 cm and 20 cm, between 0.8 cm and 20 cm, between0.8 cm and 10 cm, between 5 cm and 30 cm, between 10 cm and 30 cm,between 15 cm and 30 cm or between 20 cm and 30 cm.

In some embodiments the length of the tube 16 will be greater than 3 cm,greater than 8 cm, greater than 12 cm, greater than 18 cm, greater than22 cm or greater than 26 cm. In other embodiments the length of the tube16 will be less than 30 cm, less than 25 cm, less than 20 cm, less than15 cm, less than 10 cm or less than 5 cm.

Still referring to FIG. 1 (see also FIG. 16), in some embodiments theproximal end 3 of the hollow tube 16 is longitudinally more rigid thanthe distal end 14. In other embodiments, proximal end 3 of the hollowtube 16 is longitudinally less rigid than the distal end 14. Thedifference in rigidity may be important to improving comfort to apatient, e.g., less rigid within the proximal region 22, or providingattributes to enhance a medical personnel's ability to manipulateinstruments through the tube, e.g., more rigid in the distal region 18.In certain embodiments the entire tube 16 will have the same rigidity orflexibility. However, in other embodiments the rigidity may differbetween the distal 14 and proximal 3 ends or the distal 18 and proximalregions 22 of the tube 16. In some embodiments the tube may comprisethree regions, a proximal region 22, a medial region 20 and a distalregion 18. Each region may have a different rigidity or similarrigidity.

In certain embodiments the rigidity of the one region to another region,or proximal end 3 to distal end 14 (and vice versa), may be at least 1.0time more rigid, at least 1.5 times more rigid, at least 2.0 times morerigid, at least 2.5 times more rigid, or at least 3.0 times for rigid.In additional embodiments the difference in rigidity between regions onthe hollow tube may be between 1.0 and 10 times, between 2.0 and 8.0times, or between 3.0 and 6.0 times.

Still referring to FIG. 1, the tube 16, and sometimes the entire deviceis made from silicone or latex, although any biocompatible material issuitable. In a preferred embodiment the tube or the device issubstantially clear.

Still referring to FIG. 1, the first cap 2 is operatively configured forsecurely attaching to the proximal end 3 of the tube 16. The secureattachment may occur through a variety of suitable arrangements,including typical male-female connections. In an embodiment the firstcap 2 snaps into the opening in the proximal end 3 of the tube 16 (e.g.,FIG. 2). In all methods of secure attachment once the first cap issecurely attached to the proximal end, the proximal end is no longeropen and a force is required to disengage the first cap 2 from theproximal end 3.

When the first cap 2 is securely attached to the proximal end 3 of thetube 16, the inflation port 6 and inflation port valve 4 are recessedwithin the proximal end 3 of the hollow tube 16, e.g., FIGS. 2 and 4.This configuration allows the medical device to have a lower and smallerprofile upon insertion to the patient, e.g., the amount of the devicethat protrudes above the patient's suprapubic skin 8 is reduced byallowing the inflation port 6 and inflation port valve 4 to recesswithin the hollow tube 16.

In an embodiment the inflation port 6, the inflation port valve 4, thehollow flexible stem 26 and the separate channel 25 are in fluidcommunication and isolated from any fluid that may flow between thepatient's skin surface at the suprapubic region 8 and the patient'sbladder 10 via the tube 16.

The inflation port 6 on the bottom surface of the cap 2 is capable ofreceiving liquid via a syringe 29 or equivalent device. In someembodiments, the inflation port 6 has a built in one way valve toprevent liquid from accidently or inadvertently flowing out theinflation port 6 without operator manipulation. In other embodiments, aninflation port valve 4 is also present and performs substantially thesame function, i.e., prevent liquid from accidently or inadvertentlyflowing out the inflation port 6 without operator manipulation.

In some embodiments, the medical device further comprises an inflatableballoon-like component 12 that is fluidly connected to the separatechannel 25 and capable of receiving air or liquid via the inflation port6. The balloon like component 12 is affixed to the tube 16 prior toinsertion of the medical device into a patient. The balloon-likecomponent 12 may be affixed to the tube 16 in a variety of fashionsincluding affixation to the exterior surface of the tube 16, theinterior surface of the tube 16, directly to the separate channel 25, orsome combination thereof. In all embodiments the balloon-like componentis in fluid communication with the separate channel 25 and fluidlyisolated from the tube 16 or patient's bladder 10.

When the medical device is inserted into a patient the balloon-likecomponent 12 is substantially empty of water or air, i.e., deflated asshown in FIG. 1. Following insertion of the medical device, theballoon-like component 12 is inflated using liquid or air via theinflation port 6 as shown in FIG. 3. Upon inflation, the balloon-likecomponent rests against the bladder wall to help hold the medical devicein place and prevent the medical device from backing out of the patient.In some instances, the inflated balloon-like component will act as aplug to help prevent liquid from inadvertently leaking from the bladdervia the channel in the patient's suprapubic region, i.e., not via themedical device. In a preferred embodiment, the balloon-like componenthas a donut-like shape when inflated as opposed to a morebasketball-like shape. When it is necessary to remove the medicaldevice, liquid or air is removed from the balloon-like component via theinflation port 6. Removal of the liquid or air deflates the balloon-likecomponent 12, allowing removal of the medical device.

In some embodiments, the balloon-like component 12 is substantiallyflush with the distal end 14 of the tube 16 after inflation. In otherembodiments the balloon-like component 12 is recessed from the distalend 14 of the tube 16 after inflation, i.e., the balloon-like componentis a small distance toward the proximal end 3 of the tube therebyleaving a gap between the distal end 14 of the tube and the inflatedballoon-like component 12. The placement of the balloon-like component12 at a flush or recessed position with the distal end 14 preventsmedical instruments from contacting and possibly puncturing theballoon-like component during procedures. In addition, the location ofthe balloon-like component prevents it from interfering with the flow offluids, i.e., urine, between the surface of the patient's skin and thepatient's bladder via the tube 16.

Referring to FIG. 1, in some embodiments the proximal end 3 of the tube16 may further comprise a one way valve 24 located within the tube 16 ofthe medical device to prevent liquid from traveling from the patient'surinary bladder to the proximal surface of the patient's suprapubicregion without additional manipulation. In an embodiment the one wayvalve 24 prevents the flow of liquid irrespective of whether the firstcap 2 is securely configured to the proximal end 3 of the tube 16.Therefore, in an embodiment the one way valve 24 prevents liquid fromescaping the bladder when the first cap is not securely attached to theproximal end of the tube. In some embodiments the one way valve 24allows liquid, e.g., urine, to travel from the bladder upon manipulationby medical personnel or patient, for example, following the attachmentof a catheter drainage tube to the proximal end of the medical device.

In some embodiments the one way valve is flexible, e.g., rubber orlatex, and allows the insertion of medical instruments through the tubeinto a patient's bladder without breaking or substantially altering thepurpose of the one way valve 24.

Referring now to FIG. 4 and FIG. 5 which disclose an alternative sideprofile (FIG. 4) or top profile (FIG. 5), rotated 90 degrees from FIG.1-3, of embodiments of the medical device with an emphasis on theproximal end of the medical device. In FIG. 4, the first cap 2 alongwith an inflation port 6 and inflation port valve 4 are securelyattached to the proximal end of the tube 16. The flexible stem is notshown in FIG. 4 as it is hidden behind the first cap 2. Shown in FIG. 4is an embodiment of the medical device that includes suture anchors 30for suturing the medical device to the patient's skin after insertion ofthe device. The suture anchors 30 are located within the retention wings34 that span out from the proximal end 3 of the tube 16. As shown inFIG. 4, the suture anchors are hollow holes within a raised portion ofthe retention wings 34 that allow a medical operator to thread a suturethrough the holes and into a patient's skin. While hollow holes areshown in FIG. 4, the suture anchors 30 may take on any number ofconfigurations suitable for helping maintain the placement of thesuture, e.g., indentations in the surface of the retention wings 34 orraised bevels on the surface of the retention wings 34. There may be asingle suture anchor 30 or a plurality of suture anchors 30.

The retention wings 34 protrude outward from the first cap 2 as shown intop view of the medical device with a first cap 2 securely attached tothe proximal end of the tube 16 in FIG. 5. As shown in FIG. 4 theretention wings 34 have a low profile and sit adjacent to a patient'sskin following insertion of the medical device. As shown in FIG. 5 theretention wing ends 28 are a circular shape; however, the retention wingends 28 may take on any shape. In one embodiment, the retention wingends 28 are wider than the suture anchors 30 to help stabilize thesutures. The retention wings 34 not only provide a platform for thesuture anchors 30 but also provide a surface area to oppose theballoon-like component 12 following inflation. This oppositionstabilizes the placement of the medical device and prevents the medicaldevice from inadvertently being pushed farther into the patient orpulled out of the patient.

Referring now to FIG. 8, the retention wings 34 are elastic and flexiblein some embodiments. In these embodiments medical personnel or a patientmay use the retention wings 34 to grip the medical device duringinsertion or removal by using an opposing finger and thumb to pushinward and upward (as indicated by the arrows). The flexibility of theretention wings 34 provides better grip and control over the deviceduring placement and removal.

Some embodiments of the medical device will comprise a locking mechanismat the proximal end 3 of the tube 16, e.g., as shown in FIG. 6 and FIG.7. FIG. 6 and FIG. 7 are both a top view of an embodiment of the medicaldevice when the first cap 2 with inflation port 6 are not securelyattached to the proximal end 3 of the tube 16, e.g., the first cap 2 isin an open configuration and the viewer is looking directly down thetube 16. The locking mechanism is used to attach external devices, e.g.,drainage tubing, to the proximal end of the medical device. For example,when a patient or medical personnel desires to drain the bladder of thepatient, they may open the cap 2, and attached a drainage tube to theproximal end 3 of the tube 16 so that the drainage tube and tube are influid communication via the locking mechanism. The locking mechanismholds the drainage tube in place and allows liquid to flow freely fromthe patient's bladder to a source outside the patient's body. It isimportant to note that the presence of the locking mechanism does notprevent instrument access to a patient's bladder via the tube 16 when adrainage tube is not attached to the tube 16.

In some embodiments, the medical device further includes cathetertubing, e.g., drainage tube, that is manufactured and sold with at leastone end of the tubing configured to operatively connect to a specificlocking mechanism on the proximal end 3 of the tube 16. In someembodiments, when the medical device has a locking mechanism, themedical device also comes with a separate corresponding mate to thelocking mechanism that can connect (plug into an open end of the tubingor clamp around an open end of the tubing) to standard catheter tubingthereby allowing the standard catheter tubing to operatively connect tothe locking mechanism of the medical device.

FIG. 6 shows an embodiment of the present disclosure with a twistlocking mechanism 38 that allows the connection of external devices viathe twist lock 38. This locking mechanism, usually made of plastic, haskey holes that match the external drainage tubing teeth. Once theexternal drainage tubing with teeth are placed into position, thepatient or medical personnel placing the tubing just twists the drainagetubing teeth to the right and the drainage tubing teeth lock into place.Once drainage is finished, a simple twist in the opposite directionmoves the teeth back into the keyhole tracts and one lifts the tubingout.

FIG. 7 shows an embodiment of the present disclosure with a push-buttonlocking mechanism. This locking mechanism (usually made of plastic) hastwo sets of teeth or pins 40 and 42 that when in an untouched or naturalstate are plunged toward the center of the tube. When medical personnelor patient wants to insert a drainage tube, the teeth or pins 40 and 42are pinched open by applying pressure to the opposite ends of the tube16 to allow placement of the drainage tubing. Once the tubing is inplace, the pressure is released and the teeth 40 and 42 settle in andlock over a ridge on the drainage tubing. In some embodiments, notlocking mechanism is necessary or alternative mechanisms for connectingexternal tubing or instruments are employed.

Referring now to FIGS. 9 a and 9 b, some embodiments of the presentdisclosure comprise a ridge 44 at the proximal end of the tube 16. Theridge sits above the surface of the retention wings 34 and does notinterfere with the ability of the first cap 2 to securely attach to theproximal end of the tube 16. In some embodiments the attachment of thefirst cap 2 to the proximal end of the tube is via the ridge 44. Theridge 44 is operatively configured to accept a second cap 46 via athread mechanism, a snap mechanism or similar removable but secureattachment. A second cap 46 is independent of the medical device and isnot permanently attached to the medical device. Medical personnel mayscrew or snap a second cap 46 into place via the ridge 44 when the firstcap 2 is in the open position, e.g., FIG. 3.

A second cap 46 may be solid, i.e., have not holes or may include avariety of ports 48-66 as shown in FIG. 10 a-10 e. The ports may take ona circular shape or any other shape and size, and may be placed atdistinct positions within a second cap. In an embodiment a second caphas two circular ports (FIG. 10 e) and is placed over the open proximalend of a tube via the ridge 44. In an embodiment each port has a rubbercover that may be penetrated by an instrument medical personnel mayplace into the patient's bladder via the medical device. In someembodiments the rubber covers have flexible slits 69 that enhancepenetration by a medical instrument.

In an embodiment medical personnel may remove the first cap 2 and placea second cap 46 with two ports 66 and 68 onto the medical device via theridge 44. The medical personnel will then access the patient's bladderfor purposes of treatment or diagnosis with instruments via the twoports 66 and 68. One advantage of using a second cap 46 with ports is todecrease the size of the opening directly into the patient's bladder viathe medical device and minimize the chance of infection.

A major advantage to the medical device of the present disclosure isthat is minimizes the amount of the device protruding from a patient'ssuprapubic region by putting the inflation port 6 into the first cap 2of the device. This is a huge advantage over current devices because itless likely to become inadvertently removed, decreases the chances forinfection and increases patient comfort. This leads to increased patientconfidence and the likelihood a patient will comply with treatment. Insome embodiments, the proximal end 3 of the device with first cap 2 andretention wings 34 sits substantially flush with the skin of the patientafter insertion of the device. In an embodiment the top of the medicaldevice after insertion into a patient is less than 1 inch from thepatient's skin, less than 0.75 inches from the patient's skin, less than0.5 inches from the patient's skin, less than 0.4 inches from thepatient's skin, is less than 0.3 inches from the patient's skin, is lessthan 0.2 inches from the patient's skin, is less than 0.1 inches fromthe patient's skin.

In an embodiment, the inflation port of the medical device is at leastpartially beneath the skin of the suprapubic region of the patient afterinsertion of the device and when the cap is securely attached to theproximal end of the tube.

Referring now to FIG. 11 where an example method 70 for replacing an oldmedical device spanning the suprapubic region and urinary bladder of apatient with a device of the present disclosure is described. First,medical personnel insert a guide wire into the hollow channel of the olddevice 72. The old device is then removed by slipping it over the guidewire and leaving the guide wire in place, i.e., spanning the distancebetween the patient's suprapubic region and urinary bladder 74. A deviceof the present disclosure is then inserted over the guide wire and intoposition 76.

FIG. 12 discloses an additional method 80 of the present disclosure.First medical personnel insert a guide wire into the hollow channel ofthe old device 82. The old device is then removed by slipping it overthe guide wire and leaving the guide wire in place, i.e., spanning thedistance between the patient's suprapubic region and urinary bladder 84.The bladder of the patient if then filled with liquid to expand thepatient's bladder 86. The distance between wall of the patient's bladderand the surface of the patient's suprapubic region is measured, e.g.,using a depth gauge 88. Measuring the distance allows the medicalpersonnel to choose a medical device of the present disclosure with thebest length for fitting the patient. In an embodiment the depth gauge isdesigned much like a council tip catheter with a drainage attachmentarea and balloon inflation port at one end, which allow for access of aguide wire during placement and balloon inflation and deflation whiledetermining the depth of device necessary for patient body size. Thedepth gauge can be clear and have black hash marks on the side measuringthe distances from just above the balloon to almost the drainage tip.There is a moveable surface lock that rests on the skin edge, where thedepth gauge disc will rest, and will define the depth of the deviceneeded, by looking at the hash mark that it relates to. The internal endof the depth gauge has a balloon for inflation and to hold depth gaugein place while measuring, and has a council tip that allows for theguide wire to pass through centrally.

Still referring to FIG. 12, after determining to the depth of thepreviously established tract, a properly sized medical device of thepresent disclosure is inserted into the patient over the guide wire 90.The patient's bladder is then drained 92. In some embodiments, e.g.,FIG. 13, a larger tract may be necessary then the tract previouslyestablished by the old medical device. In this situation, medicalpersonnel may dilate the existing tract to a desire french size 106 inbetween removing the old device 104 and inserting the new device 112.

Referring now to FIG. 14 where a method 120 for inserting device bycreating a new tract between a patient's suprapubic region and urinarybladder is disclosed 120. First medical personnel will insert a needleabove the patient's pubic symphisis into the patient's urinary bladder122. A guide wire is then threaded through the needle 124. The needle isremoved and a medical device is inserted into the tract created by theneedle and over the guide wire 126.

FIG. 15 discloses an additional method 130 for inserting a device bycreating a new tract between a patient's suprapubic region and urinarybladder. To aid the medical personnel in creating new tract a cystoscopeis placed into the patient's bladder via the patient's urethra 132.Medical personnel will insert a needle above the patient's pubicsymphisis into the patient's urinary bladder 134 under observation ofthe cystoscope. A guide wire is threaded through the needle 136 and theneedle is removed. The tract created by the needle and occupied by theguide wire is dilated to a desired french size 138. The depth of thetract is measured 140 using a depth gauge as previously described 88 andin some embodiments the bladder may be filled with liquid prior tomeasuring the depth. The device is selected based on the measured depthand inserted into the patient over the guide wire through the newlyformed tract 142. In some embodiments the patient's bladder is thendrained if it was full or had been filled earlier in the procedure 144.

A method for inserting a medical device is disclosed comprisinginserting a needle from a patient's exterior surface of a suprapubicskin through the patient's abdominal region and into the patient'surinary bladder to create a tract. Threading a guide wire through theneedle so the guide wire travels from the suprapubic skin into theurinary bladder and removing needle while leaving the guide wire in thetract. Dilating the tract to a desired width and measuring a distancebetween the patient's suprapubic skin and the patient's urinary bladdervia the tract. And inserting a medical device suitable for use based onthe previously measure distance.

In another embodiment a method for replacing a medical device comprisesplacing a guide wire from a patient's suprapubic skin through thepatient's abdominal region and into the patient's urinary bladder, theguide wire traveling from the suprapubic skin into the urinary bladderwithin a previously placed medical device. And removing the previouslyplaced medical device by sliding the device along the guide wire andaway from the patient; filling the bladder of the patient and measuringa distance between the patient's suprapubic skin and the patient'surinary bladder; selecting a second medical device suitable for usebased on the previously measured distance and inserting the selectedmedical device; and draining the urinary bladder of the patient.

It should be noted that the suprapubic location of the medical devicedecreases infection rates in comparison to intraurethralcatheterization. In addition, the low profile design of the medicaldevice has less material for contact and infection. In addition, anantimicrobial may be applied to the entire device or the tube to reducethe possibility of infection and increase the length of use overtraditional suprapubic tubes.

While reference has been made to a patient throughout the specificationit should be appreciated that that the patient could be any mammal.

Example 1

A medical device of the present disclosure was placed into a previouslyexisting suprapubic tract. A guide wire was placed through the devicecurrently in place and the old device was removed over the wire. A depthgauge was placed over the guide wire until then end with a balloon wasin the bladder and then the balloon was inflated. The patient's bladderwas filled with water and the clamp on the surface of the depth gaugewas clamped. The moveable surface lock on the depth gauge was moved tothe skin surface while holding up on the depth gauge. The depth wasmeasured. A matching size device of the present disclosure was selected.The depth gauge was removed and the selected device was placed over thewire and threaded into the bladder. The balloon-like component on theselected device was inflated following insertion into bladder. Thebladder was drained after connecting drainage tubing via a lockingmechanism to the inserted device. The drainage tubing was removed andthe first cap was securely attached to the proximal end of the device.The patient was instructed on use of the inserted device and how oftentheir bladder should be drained via the inserted device.

Example 2

A medical device of the present disclosure was placed into a new patientby creating a new suprapubic tract. A cystoscope was placed via urethrainto the bladder and the bladder was filled with liquid. An 18 gaugespinal needle was inserted into the patient approximately twofingerbreadths above the pubic symphisis in the midline until urinereturned from the needle and needle was visualized through thecystoscope. A guide wire was threaded through the needle. The tract wasdilated using an Amplatz balloon dilating system (but any means ofdilating will work) to the desired French size. A depth gauge was placedover the wire until the balloon was in the bladder and the balloon wasinflated. The patient's bladder was refilled and the depth gauge wasclamped. The moveable surface lock on the depth gauge was moved to thepatient's skin surface while holding up on the depth gauge and the depthwas measured. A matching size device of the present disclosure wasselected. The depth gauge was removed and the selected device was placedover the wire and threaded into the bladder. The balloon-like componenton the selected device was inflated following insertion into bladder.The bladder was drained after connecting drainage tubing via a lockingmechanism to the inserted device. The drainage tubing was removed andthe first cap was securely attached to the proximal end of the device.The patient was instructed on use of the inserted device and how oftentheir bladder should be drained via the inserted device.

Some embodiments have additional uses, for example, as a feeding tubevia port-like access to a patient's stomach, i.e., a G-button. Or forport-like access to another internal cavity of a patient. Those skilledin the art will appreciate that the present invention may be embodied byforms that are not disclosed without departing from the spirit orfundamental attributes thereof. While the present disclosure describesonly some of the possible embodiments, a skilled artisan will appreciatethat other variations are contemplated as being with the scope of thepresent invention. Accordingly, the present invention is not limited inthe particular embodiments which have been described in detail therein.Since many embodiments of the invention can be made without departingfrom the spirit and scope of the invention, the invention resides in theclaims hereinafter appended.

What is claimed is:
 1. A medical device comprising: a continuous hollowtube, the length sized for spanning the distance between an exteriorsurface of a mammal's suprapubic region and the mammal's urinarybladder, the hollow tube having an open proximal end and an open distalend; a first cap having a top surface and a bottom surface, the firstcap being operatively configured for securely attaching to the proximalend of the tube; a hollow flexible stem fluidly connecting the first capand the proximal end of the hollow tube so that liquid may pass into thebottom surface of the first cap, through the hollow flexible stem, andinto a separate channel within the hollow tube; and an inflation port onthe bottom surface of the cap, the inflation port being operativelyconfigured to receive liquid via a syringe so when the cap is notsecurely attached to the proximal end of the tube liquid may be injectedvia the inflation port and travel from the cap through the hollowflexible stem and down the separate channel within the hollow tube. 2.The medical device of claim 1 wherein the continuous hollow tube has adiameter between 10 french and 40 french and the proximal end of thehollow tube is longitudinally more rigid than the distal end.
 3. Themedical device of claim 2 wherein the diameter of the continuous hollowtube is between 20 and 30 french.
 4. The medical device of claim 2wherein the diameter of the continuous hollow tube is greater than 30french.
 5. The medical device of claim 2 wherein the diameter of thecontinuous hollow tube is less than 20 french.
 6. The medical device ofclaim 2 wherein the rigidity of the proximal end of the hollow tube is1.2 times the rigidity of the distal end.
 7. The medical device of claim2 further comprising a medial region located between the proximal endand the distal end of the hollow tube and having a rigidity less thanthe proximal end and greater than the distal end.
 8. The medical deviceof claim 1 wherein the first cap covers the open proximal end of thetube when securely attached to the proximal end of the tube and thebottom surface of the cap is recessed within the proximal end of thetube upon secure attachment.
 9. The medical device of claim 1 whereinthe separate channel runs from the proximal end of the hollow tubetoward the distal end of the hollow tube and the hollow flexible stem ispermanently attached to the hollow tube below the open proximal end ofthe hollow tube.
 10. The medical device of claim 1 further comprising asecond cap having top surface and a bottom surface that is operativelyconfigured to securely attach to the proximal end of the tube, thesecond cap having at least one port from the top surface through to thebottom surface.
 11. The medical device of claim 1 further comprising aone way valve located within the tube of the medical device to preventliquid from traveling from the mammal's urinary bladder to the proximalsurface of the mammal's suprapubic region when the first cap is notsecurely attached to the proximal end of the tube.
 12. The medicaldevice of claim 1 further comprising an inflatable balloon along theexterior surface of the hollow tube and in fluid communication with theinflation port via the separate channel within the hollow tube.
 13. Themedical device of claim 1 wherein the length of the continuous hollowtube is between a length between 0.8 cm and 15 cm.
 14. The medicaldevice of claim 1 wherein the length of the continuous hollow tube isgreater than 8 cm.
 15. The medical device of claim 1 wherein the lengthof the continuous hollow tube is less than 10 cm.
 16. The medical deviceof claim 1 wherein the proximal end of the device sits substantiallyflush with the skin of the suprapubic region of the mammal afterinsertion of the device into the mammal.
 17. The medical device of claim1 wherein the inflation port of the device sits at least partiallybeneath the skin of the suprapubic region of the mammal after insertionof the device and when the cap is securely attached to the proximal endof the tube.